Migea

Leaflet attached to the packaging: patient information

Migea, 200 mg, tablets

Tolfenamic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
Keep this leaflet, you may need to read it again.
If you need advice or additional information, consult a pharmacist.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.
See section 4.
If there is no improvement after 3-4 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Migea and what is it used for
• 2. Important information before taking Migea
• 3. How to take Migea
• 4. Possible side effects
• 5. How to store Migea
• 6. Package contents and other information

1. What is Migea and what is it used for

Migea contains the active substance tolfenamic acid - a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic effects.
The indication for the use of Migea is an acute migraine attack.
Migraine is characterized by a pulsating, one-sided, moderate or severe headache, which may worsen during physical exertion. It is sometimes accompanied by nausea, vomiting, and hypersensitivity to light, sound, and smell.
The headache may sometimes be preceded by certain symptoms, such as a short-term deterioration of mood, irritability, anxiety, or loss of appetite. In some people (10-20%), a so-called aura (transient visual disturbances with a sensation of light flashes, shimmering spots, or light lines) may appear shortly before the onset of the headache.

2. Important information before taking Migea

When not to take Migea

if the patient is allergic to tolfenamic acid or any of the other ingredients of this medicine (listed in section 6);
if the patient has asthma or if the administration of Migea or similar-acting medicines, such as other non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) or salicylates (e.g., acetylsalicylic acid), has caused an asthma attack, hives, angioedema, or acute rhinitis in the past;
if the patient has severe heart failure;
if the patient has severe kidney failure;
if the patient has severe liver failure;
if the patient has gastrointestinal bleeding, cerebral vessels, or other active bleeding;
if the patient has currently or has had a history of gastric or duodenal ulcer, has had gastrointestinal bleeding, ulceration, or perforation, also caused by the use of non-steroidal anti-inflammatory drugs;
if the patient is in the third trimester of pregnancy.
The medicine should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before taking Migea, the patient should discuss it with their doctor or pharmacist.
The patient should inform them about all current and past health disorders, especially the following:

• liver or kidney function disorders;
• chronic diseases, such as systemic lupus erythematosus or mixed connective tissue disease;
• hypertension and/or heart function disorders, as well as edema;
• gastrointestinal diseases, such as ulcerative colitis, Crohn's disease;
• blood clotting disorders or other blood diseases;
• vascular disease (peripheral or cerebral).

Non-steroidal anti-inflammatory drugs (NSAIDs) may cause interstitial nephritis, nephrotic syndrome, renal papillary necrosis, or nephrotic syndrome.
Smoking, excessive alcohol consumption, and poor general health increase the risk of gastrointestinal side effects in the patient.
The patient should avoid concurrent use of this medicine and other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors (e.g., meloxicam, nimesulide, nabumetone).
The patient should consult their doctor or pharmacist if they are taking or have taken medicines that reduce blood clotting (anticoagulants), diuretics, or medicines that may increase the risk of gastrointestinal ulceration or bleeding (see below "Migea and other medicines").
During the use of Migea, the patient's skin may be more sensitive to the harmful effects of sunlight. The patient should avoid exposure to sunlight and UV radiation (e.g., in a solarium) and use appropriate skin protection measures.
Migea has analgesic, anti-inflammatory, and antipyretic effects, so it may mask the symptoms of an underlying infection (such as headache, fever). If the patient visits a doctor, they should inform them about the use of this medicine.
If urinary disorders occur during treatment, the patient should drink more fluids.
Patients with hypertension and/or heart failure, fluid retention, and edema should consult their doctor or pharmacist before taking Migea, as non-steroidal anti-inflammatory drugs have caused fluid retention, hypertension, and edema in some patients.
Taking such medicines as Migea may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke). This risk increases with long-term use of high doses of the medicine. The patient should not take higher doses or use the medicine for longer than recommended.
Long-term use of painkillers may lead to worsening of headaches. The patient should consult their doctor in such cases. If the patient frequently or daily experiences headaches despite (or due to) regular use of painkillers, they should consult their doctor.
The medicine should be used with caution in patients with bronchial asthma, as cases of bronchospasm have been reported after administration of non-steroidal anti-inflammatory drugs. Bronchospasm can be life-threatening.
If the patient experiences any of the following during the use of Migea:
gastrointestinal bleeding,
rash and/or mucosal lesions,
other symptoms of hypersensitivity,
they should stop taking the medicine and contact their doctor immediately.
Use of Migea in the elderly
The elderly may be more sensitive to the effects of the medicine, and side effects caused by non-steroidal anti-inflammatory drugs (especially gastrointestinal bleeding and perforation, which can be fatal) as well as worsening of liver, kidney, or heart function may occur more frequently. The patient should follow the recommendations in the leaflet, use the smallest effective dose, and report all side effects to their doctor.

Migea and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Migea and some concurrently taken medicines may interact with each other and affect their efficacy and the occurrence of side effects. This applies in particular to such medicines as:
methotrexate (a medicine used to treat certain cancers or arthritis);
cyclosporin (a medicine that reduces the body's immune response);
tacrolimus (a medicine with anti-inflammatory effects);
lithium (a medicine used to treat depression);
corticosteroids (medicines with anti-inflammatory effects);
other painkillers;
other non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or salicylates (e.g., acetylsalicylic acid);
diuretics;
medicines used to treat high blood pressure (antihypertensive medicines);
antibiotics from the quinolone group;
anticoagulant medicines (such as warfarin, acenocoumarol);
medicines that inhibit platelet aggregation (antiplatelet medicines);
antidepressant medicines (from the group of selective serotonin reuptake inhibitors);
digitalis glycosides, e.g., digoxin (medicines used to treat heart conditions);
antiepileptic medicines (e.g., phenytoin);
oral antidiabetic medicines;
medicines that neutralize stomach acid, containing aluminum hydroxide;
mifepristone (a medicine used, among others, to treat uterine fibroids);
zydovudine (a medicine used to treat HIV infection).
In case of doubt whether the patient is taking any of the mentioned medicines, they should consult their doctor or pharmacist.

Migea with food, drinks, and alcohol

Migea tablets can be taken regardless of meals.
The patient should not drink alcohol during the use of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should not take Migea if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Migea may cause kidney and heart function disorders in the unborn child. It may increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Migea should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Migea may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
A negligible amount of tolfenamic acid passes into breast milk. If the use of the medicine during breastfeeding is necessary, the patient should consult their doctor.
Fertility
Tolfenamic acid may make it difficult to conceive. If the patient plans to become pregnant or is having difficulty conceiving, they should consult their doctor.

Driving and using machines

No effects of Migea on the ability to drive and use machines have been observed.
However, if the patient experiences dizziness, drowsiness, fatigue, or vision disturbances, they should not drive or operate machinery.

Migea contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Migea

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for oral use.
Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects.
Adults and the elderly
1 tablet (200 mg of tolfenamic acid) after the first symptoms of an acute migraine attack appear.
If there is no improvement, the dose can be repeated after 1 to 2 hours.
The patient should not take more than 2 Migea tablets (400 mg of tolfenamic acid) per day.
The tablet should be swallowed whole, with a glass of water.
Children and adolescents
The medicine should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Migea than recommended

In case of taking a higher dose of Migea than recommended, the patient should immediately consult their doctor or pharmacist.
Symptoms of overdose may include: headache, nausea, vomiting, abdominal pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitement, coma, drowsiness, dizziness, tinnitus, fainting, very rarely seizures. Significant poisoning may cause kidney failure and liver damage.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine is generally well-tolerated when used in recommended doses.
Taking such medicines as Migea may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. The patient should not take higher doses or use the medicine for longer than recommended.
The following side effects are possible during the use of this medicine:
Very commonside effects (may occur in more than 1 in 10 people):
diarrhea, nausea.
Commonside effects (may occur in less than 1 in 10 people):
indigestion, vomiting, abdominal pain, hives, rash, burning sensation while urinating, urine discoloration, headache, dizziness, fatigue, liver function disorders.
Uncommonside effects (may occur in less than 1 in 100 people):
bloating, feeling of fullness, loss of appetite, constipation, increased creatinine levels in serum, increased blood urea nitrogen levels, increased sweating, tingling, disorientation, facial flushing, decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia), decreased granulocyte count (granulocytopenia), increased eosinophil count (eosinophilia), anemia.
Rareside effects (may occur in less than 1 in 1000 people):
insomnia, anxiety, tremors, tinnitus, bronchospasm, asthma attacks, shortness of breath.
Very rareside effects (may occur in less than 1 in 10,000 people):
edema, heart failure, gastric or duodenal ulcer, perforation, or gastrointestinal bleeding (sometimes fatal, especially in elderly patients), exacerbation of intestinal inflammation and Crohn's disease, tarry stools and bloody vomiting, gastritis, skin lesions (including Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity to light, urinary retention (anuria), hematuria, kidney pain, frequent urination (pollakiuria), euphoria, hyperesthesia, hypoesthesia, depression, hypertension or hypotension, allergic interstitial lung disease, pulmonary infiltrates with eosinophilia, pulmonary fibrosis, hemoptysis, toxic hepatitis, hemolytic anemia (anemia due to red blood cell destruction), agranulocytosis (complete or almost complete lack of granulocytes), pancreatitis, oral mucositis.
Frequency not known(frequency cannot be estimated from the available data):
vision disturbances, optic neuritis, aseptic meningitis (especially in patients with autoimmune diseases, i.e., systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation, hallucinations, malaise, and drowsiness, jaundice, decreased granulocyte count (neutropenia), non-specific allergic reactions and anaphylaxis, itching, purpura, angioedema, erythema multiforme, interstitial nephritis, nephrotic syndrome, and kidney failure.
The risk of side effects is higher in the elderly. This risk is further increased in patients with kidney, liver, or heart failure.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Migea

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Migea contains

The active substance of the medicine is tolfenamic acid. One tablet contains 200 mg of tolfenamic acid.
The other ingredients are: corn starch, sodium carboxymethylcellulose (type A), macrogol 6000, alginic acid, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.

What Migea looks like and what the package contains

Migea tablets are white, oval, biconvex, with a dividing line on one side and the marking "FM7" on one side of the line and "GEA" on the other side. The medicine is packaged in blisters and cardboard boxes.
The package contains 4 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer:

FAMAR S.A.
7 Anthoussas Av.
153 44 Anthoussa Attiki, Greece
Sandoz A/S
Edvard Thomsens Vej 14
2300 Copenhagen S, Denmark
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
For more information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

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